Medical device regulations barrier cleared

Medical device regulations clear final barrier to adoption

European Parliament gives positive votes on the EU regulations for medical devices and IVDs

The long-awaited EU Medical Devices Regulation (MDR) and In Vitro Diagnostic medical devices Regulation (IVDR) received a positive vote in the European Parliament on 5th April. Medical device manufacturers, Notified Bodies and Competent Authorities have been holding their breath in case of a last-minute hitch. But in the end, both Regulations had a substantial majority for adoption.

Following these positive votes, it should take about six weeks for the final text to be published in the Official Journal. At this point, the Regulations will each have their unique identifying numbers. They will enter into force 20 days after publication. So, the transition periods should start in late May 2017, and run for three years for medical devices and five years for IVDs. Notified bodies can apply for designation under the regulations six months after the entry into force but the designation process could take until 2019.

The end of the transition period marks the date of application of the regulations. This is when the Active Implantable Medical Devices Directive (AIMD), Medical Devices Directive (MDD) and In Vitro Diagnostic Medical Devices Directive (IVDD) are repealed. Devices with valid certificates under the MDD and AIMD can continue to be placed on the market for the period of validity of these certicates - or for up to four years after the date of application - whichever is the shorter. IVDs with valid certificates under the IVDD have up to two years after the date of application of the IVD Regulation because of the longer transition period - but many IVDs are self-certified under the IVD Directive and so don’t have certificates. However, some requirements of Regulations, such as those for post-market surveillance, vigilance reporting and registration, will apply to devices with valid certificates under the Directives from the date of application - that is in just three years’ time for medical devices and five years for IVDs.

If you haven’t started your transition planning, you need to start now. Failing to be ready in time could stop you selling your devices in the EU. BSI’s free white papers and Compliance Navigator can help you. 

 

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.